MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER; CATHETER, PERIPHERAL, ATHERECTOMY

Model Number UNAVAILABLE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Embolus (1830); Iatrogenic Source (2498)

Event Date 09/01/2016

Event Type  Injury  

Manufacturer Narrative

Patient information unavailable.Device model, lot number, expiration date and udi unavailable.Physician name, phone and email unavailable.510k unavailable because device model and lot numbers unavailable.Device manufacture date unavailable because lot number unavailable.

Event Description

The manufacturer was made aware on 12 sept 2020 of a literature review performed by china.This report has been submitted to capture an adverse event described in the journal article from "chin j gen surg, august 2019, vql 34, no.8" titled "excimer laser atherectomy combined with drug-eluting balloon for lower limb arteriosclerosis obliterans".According to the article, the clinical data was retrospectively analyzed of 42 patients with lower limb arteriosclerosis obliterans, who underwent excimer laser atherectomy (ela) + drug coated balloon (dcb) from sep 2016 to dec 2018 in the department of vascular surgery of beijing hospital.In the article, the event date was not documented; therefore the date of 1 sept 2016 was chosen to capture the earliest time frame in which the patients underwent the procedures.In this procedure applicable to this report, a spectranetics turbo elite laser atherectomy catheter was reportedly used.Concomitant devices were reportedly used during the 42 procedures as well, but the article did not specify which of the devices was used to treat this patient's lesion.The article went on to state that after ela was performed, an embolization occurred in the patient's tibial-peroneal trunk.Partial thrombus aspiration was performed with a 6f guiding catheter under negative pressure, followed by a dilation of the occluded vessel segments using a 3mm balloon (biotronik, germany), and then the distal blood flow was restored.The patient survived the procedure.There was no alleged malfunction of the turbo elite device in use during the procedure.

• Brand Name: SPECTRANETICS TURBO ELITE LASER ATHERECTOMY CATHETER
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 10612923
• MDR Text Key: 209371160
• Report Number: 1721279-2020-00203
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): Y
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature,study
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNAVAILABLE
• Device Catalogue Number: UNAVAILABLE
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 6F GUIDING CATHETER MANUFACTURER UNKNOWN; BIOTRONIK 3MM BALLOON; SPECTRANETICS CVX-300 EXCIMER LASER SYSTEM
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention